The objective of this trial is to determine if reducing the chemotherapy dose in electrochemotherapy is equally effective as using the standard dose for treating various types of skin tumors.
Electrochemotherapy involves administrating chemotherapy intravenously, followed shortly by a brief electrical pulse to the tumor. This pulses temporarily increases the tumor cells permeability, allowing the chemotherapy to enter more effectively.
Participants will undergo a single session of electrochemotherapy with either half the standard chemotherapy dose or the full standard dose. The size of the cutaneous tumors will be measured before treatment and again three months after the treatment to compare their response in both groups. To monitor the tumors, as well as assess the adverse events and quality of life, participants must attend follow-up visits at two weeks, three months and twelve months. Additional visits may be scheduled at one, two, four and six months, if necessary, as determined by the clinician or the patient. Concentration of chemotherapy will be measured in blood samples and in samples from the treated tumor and normal skin.
Trial subject > 18 years.
Trial subject must be able to understand the participant information.
Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.
Life expectancy > 3 months.
Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment.
Allergy or hypersensitivity to bleomycin.
Acute lung infection.
Severely impaired lung function or any lung condition the investigator deems severe.
Parallel
Bleomycin
DrugIn the standard arm, Bleomycin (Baxter, Germany) at a dose of 15.000 IU/m² is used. In the dose reduction arm, a dose of 7500 IU/m² is used. Note that in Denmark bleomycin is dosed by international units, whereas other countries may use respectively U (units) or mg.
To evaluate the clinical overall response rate of electrochemotherapy treatment of cutaneous malignancies after three months
The response to treatment will be evaluated according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Response rate will be defined as the number of responding tumours relative to the number of treated tumours (Intention to treat analysis, ITT), evaluated 3 months after treatment. The response will be evaluated by clinical examination with ruler measurements (in mm) and photographical documentation using rulers for scale.
Treatment response for normal dose group, reduced dose group, and for all treated tumors at optimnal time points using the mRECIST criteria.
Tumors size in mm are measured with a ruler and documented with digital photographies.
Aesthetic outcome for normal dose group, reduced dose group and for all tumours 3 months after treatment and 1 year after treatment, using the Vancouver Scar Scale.
The Vancouver Scar Scale assesses scars based on four criteria: vascularity, pigmentation, pliability and hight. Each scar or lesion is evaluated given a score ranging from 0 to 13, with 13 representing the most severe scar.
Aesthetic outcome for normal dose group, reduced dose group and for all tumors assessed at 3 month and 12 month, using Patient and Observer Scar Assessment Scale (POSAS).
Patient and Observer Scar Assessment Scale (POSAS) is a tool used to evaluate scars both from the patient's and the observer's persepective. Each independently completes a questionnaire assessing various aspects of the scar, such as color, thickness, and overall appearance. All questions are rated from "not" to "extreamly", to capture the severety of each feature.
Complete and partial remissions for all patients treated (patient level)
Response at patient level defined as number of patients experiencing objective responses on at least one treated tumour.
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Julie Gehl
Lead sponsor
Zealand University Hospital
Sponsor institution
Roskilde University
Collaborator
Herlev Hospital
Collaborator
